The following data is part of a premarket notification filed by Renauld Intl. Ltd. with the FDA for Non-prescription Sunglasses.
| Device ID | K901168 |
| 510k Number | K901168 |
| Device Name: | NON-PRESCRIPTION SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | RENAULD INTL. LTD. 2200 RENAISSANCE TOWER 1201 ELM STREET Dallas, TX 75270 |
| Contact | Steven P Watten |
| Correspondent | Steven P Watten RENAULD INTL. LTD. 2200 RENAISSANCE TOWER 1201 ELM STREET Dallas, TX 75270 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-13 |
| Decision Date | 1990-05-15 |